Biotech Stock Roundup: AMGN To Buy CELG's Otezla, ALXN's Soliris Gets EC Nod & More
Zacks Investment Research | Aug 27, 2019 10:34PM ET
It was a busy week for the biotech sector with updates from quite a few players. While pharma bigwig Amgen (NASDAQ:AMGN) agreed to buy Celgene’s (NASDAQ:CELG) Otezla, Alexion (NASDAQ:ALXN) won European Commission's (EC) approval for the label expansion of Soliris. Meanwhile, Gilead (NASDAQ:GILD) closed its deal with Galapagos.
Recap of the Week’s Most Important Stories:
Amgen to Acquire Celgene’s Otezla: Amgen declined after it announced the failure of its late-stage study evaluating fosmetpantotenate in patients with pantothenate kinase-associated neurodegeneration (PKAN), a rare genetic neurological disorder. The phase III study, FORT, was evaluating the safety and efficacy of fosmetpantotenate compared to placebo in 84 PKAN patients. Patients received either three times daily dosing of fosmetpantotenate or placebo using a 1:1 randomization over 24 weeks. The primary endpoint of the study was the change from baseline in the PKAN-ADL scale through 24 weeks of treatment. After completing the 24-week treatment period, all patients were eligible to receive fosmetpantotenate as part of an open-label extension study.
However, neither did the study meet its primary endpoint nor did it demonstrate a difference between treatment groups. The study also did not meet its secondary endpoint. Fosmetpantotenate was a late-stage candidate and a potential approval would have boosted the company’s top line significantly. Moreover, the failure of the study will most likely lead to the termination of the entire clinical program on this candidate.
Clearside Biomedical Plunges on Setback: Shares of Clearside Biomedical, Inc. (NASDAQ:CLSD) plummeted after the company provided an update on its New Drug Application (NDA) for Xipere (triamcinolone acetonide suprachoroidal injectable suspension) to the FDA. The FDA’s Office of Pharmaceutical Quality (OPQ) requested Clearside to provide stability data for the triamcinolone acetonide (TA) suspension produced utilizing an enhanced manufacturing process implemented by the company. Though the formulation of the TA suspension has not changed, the data was requested to verify the comparability of the stability profiles of the batches made using an enhanced manufacturing process with that of the batches originally submitted as part of the NDA.
Consequently, Clearside expects to receive a CRL from the FDA on or before its PDUFA (Prescription Drug User Fee Act) date of Oct 19, 2019. The company plans to re-submit the NDA in the first quarter of 2020 with the requested stability data.
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